3 years.
Lactose monohydrate
Cellulose, microcrystalline
Magnesium stearate
Systemic toxic effects of Fluomizin are unlikely on the basis of the negligible systemic exposure of dequalinium chloride administered intravaginally.
In vivo and in vitro studies with dequalinium chloride did not yield any indication of a potential to cause mutagenicity.
No reproduction toxicity studies have been conducted with dequalinium chloride.
A study in rabbits showed the good vaginal tolerance of Fluomizin.
11/04/2017
Kora Corporation Ltd t/a Kora Healthcare
Swords Business Park, Swords, Co. Dublin, Ireland
PL 39972/0004
To minimize exposure of the newborn to dequalinium chloride, vaginal tablets should not be used within 12 hours before birth.
There are no efficacy and safety data available on the re-treatment of patients who did not respond to or relapsed immediately after initial therapy with Fluomizin. Patients should be advised to consult their physician if the symptoms persist at the end of the treatment or in case of recurrence.
Using a higher daily dose or increasing the recommended treatment duration might increase the risk of vaginal ulcerations.
No efficacy and safety data on the treatment of bacterial vaginosis in women aged less than 18 years or more than 55 years are available.
No studies on the effects on the ability to drive and use machines have been performed.
No special requirements.
30/06/2015
Anionic substances such as soaps, detergents and surfactants can reduce the antimicrobial activity of dequalinium chloride. Thus, concomitant intravaginal use of soaps, spermicides or vaginal douches (vaginal washes) is not recommended.
Fluomizin 10 mg vaginal tablets do not impair the functionality of latex condoms. There are no data on the interaction with non-latex condoms and other intravaginal devices such as diaphragms. Thus, concomitant use of non-latex condoms and other intravaginal devices is not recommended for at least 12 hours following the treatment.
